Study Rationale: Almost all individuals with Parkinson’s disease (PD) develop episodes of freezing of gait, which is a sudden inability to take a step while walking. Gait freezing can cause falls that result in significant morbidity and possibly mortality, and it is associated with depression, social isolation and stigma. Current treatments for moderate to severe PD focus on improving rigidity and tremor, but do not treat gait freezing. In this study, we will test the accuracy of a new algorithm for detecting gait freezing episodes and develop a system for applying stimulation parameters tailored to relieve gait freezing in individuals with PD.
Hypothesis: We hypothesize that gait freezing can be ameliorated by patient-specific neuromodulation therapies aimed at retuning the brain’s oscillatory network dynamics.
Study Design: The goal of this work is to develop and make available a deep brain stimulation (DBS) system that automatically detects gait freezing episodes and once detected, modifies stimulation parameters to interrupt or prevent freezing of gait (adaptive stimulation). In the project, we will develop new algorithms that specifically adapt the stimulation to minimize freezing episodes using a novel DBS system that allows for chronic brain recording. The safety and efficacy of these novel neuromodulation modes will be tested in a clinical study, during which participants will undergo detailed gait analysis, as well as in virtual reality environments and home monitoring.
Impact on Diagnosis/Treatment of Parkinson’s Disease: This project will open a new era for PD care, tailoring DBS therapy to the individual’s needs through a brain interface that will retune neural activity to enable optimal symptom control and proper performance of motor and non-motor tasks.
Next Steps for Development: The AlphaDBS device is a DBS platform that can be implemented with new software for adaptive brain stimulation. We will develop clinical data that will ground confirmatory clinical studies aimed at gaining regulatory approval for the modified system.
Trial Phase: pre-market study (pilot)